REGENXBIO announces completion of phase I/IIA RGX-314 clinical trial
Category: #health  By Mateen Dalal  Date: 2019-06-01
  • share
  • Twitter
  • Facebook
  • LinkedIn

REGENXBIO announces completion of phase I/IIA RGX-314 clinical trial

Every subject received one dose of RGX-314 managed by subretinal delivery.

The leading clinical-stage biotechnology company REGENXBIO Inc. has recently announced that it has finished dosing across all 5 cohorts in the Phase I/IIa medical trial of RGX-314 to cure wet age-related macular degeneration.

Steve Pakola, M.D. and Chief Medical Officer, REGENXBIO, reportedly stated that patients with wet AMD need intravitreal injections every 4-12 weeks, on average, with the existing standard of care, and the company was delighted to note long-lasting response of treatment from Cohort 3 of the RGX-314 Phase I/IIa study for wet AMD at 1 year after only one administration of RGX-314 in a hugely pre-treated patient population in an earlier provisional trial update.

Reportedly, 8 leading retinal surgery centers throughout the U.S. have participated in the Phase I/IIa RGX-314 trial. It is designed to assess the RGX-314’s safety and tolerability as a one-time treatment for patients enduring wet AMD who were treated earlier with anti-vascular endothelial growth factor (VEGF) injections. There are 42 dosed subjects across 5 escalating dose cohorts in the trial. Every subject received dose of RGX-314 managed by subretinal delivery.

Robert Avery, M.D., retina surgeon and trial investigator, California Retina Consultants, reportedly stated that the constant medical durability of effect observed one year after one-time supervision of RGX-314 in Cohort 3 represents the capability of RGX-314 to deliver substantial anti-VEGF treatment that may tolerate vision gains and alleviate treatment burden for millions of patients enduring wet AMD.

Reportedly, REGENXBIO has been planning to start a Phase IIb study in wet AMD by the end of the year 2019. Phase IIb trial will be based on the data of Phase I/IIa study which will increase clinical expansion of RGX-314 by filing an Investigational New Drug (IND) application to cure diabetic retinopathy (DR) in the second half of the year 2019.

Source credit: https://regenxbio.gcs-web.com/news-releases/news-release-details/regenxbio-announces-completion-dosing-phase-iiia-clinical-trial

https://www.erienewsnow.com/story/40556288/regenxbio-announces-completion-of-dosing-for-phase-iiia-clinical-trial-of-rgx-314-in-wet-amd

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

Mateen has completed his Bachelor’s degree in electronics and telecommunication engineering, post which he lent his proficiency to the industry, working as a quality and test engineer. Drawn intricately toward the field of content creation however, Mateen soon switc...

Read More

More News By Mateen Dalal

TPG Rise Climate Fund raises $5.4Bn to support new climate solutions
TPG Rise Climate Fund raises $5.4Bn to support new climate solutions
By Mateen Dalal

TPG Rise Climate Fund, the climate investing fund of TPG’s global impact investing platform TPG Rise, has recently raised its first close of $5.4 billion, bringing together an exclusive blend of funding from some of the top institutional invest...

Baby nutrition firm ByHeart nabs $90Mn in Series B funding round
Baby nutrition firm ByHeart nabs $90Mn in Series B funding round
By Mateen Dalal

ByHeart, a fully integrated infant nutrition company, has reportedly secured $90 million in Series B funding which the company plans to use for the launch of its baby formula and support the development of its pipeline of nutrition items for chi...

UAE extends travel ban for Indians amid strict COVID-19 guidelines
UAE extends travel ban for Indians amid strict COVID-19 guidelines
By Mateen Dalal

United Arab Emirates (UAE) has reportedly extended travel ban for individuals travelling from India and several other south Asian countries on the pretext of COVID-19 guidelines. As reported by Etihad Airlines, the ban will be followed till 31st July...